Utility of Pupillary Metrics in Diagnosis and Management of Concussion in Children
Status unconfirmed
Conditions studied: Brain Concussion, Reflex, Pupillary, Post-Concussion Syndrome, Brain Injuries, Traumatic
In brief
The purpose of this study is to gather information and compare the potential use of pupillometry to identify concussions and post concussive syndrome with standard age appropriate assessments. The study will compare concussed pediatric patients 5-17 years of age recruited from the emergency department within 72 hours following injury with age and gender matched non-concussed pediatric patients recruited from primary care clinics. Assessment of both concussed and non-concussed subjects will take place at the initial enrollment visit and will be repeated at 1-2 weeks for the concussed subjects and at 12-14 weeks for both groups.
Key facts
- Study ID
- NCT04540445
- Run by
- Children's Hospital of Orange County
- People needed
- 130
- Starts
- 2020-03-11
- Expected to finish
- 2022-12-01
- Last updated by the study team
- 2022-03-11
Who can join
Age: 5 and older, up to 17. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Males or females ≥ 5 to < 18 years of age
- Patients presenting to Pediatric Emergency Department with a concussion within 72 hours following injury. Concussion will be defined as the presence of the following criteria: Post injury patient reported symptoms on an age-appropriate graded-symptom checklist that meets the borderline to extremely high threshold (sex and age adjusted)
- Age and gender matched healthy controls recruited and evaluated through Primary Care (Orange Ambulatory) and Adolescent Clinics
You may not qualify if…
- Lower extremity deficiency or injury
- History of cognitive deficiencies
- History of ≥ 3 prior concussions
- History of attention deficit disorder
- Previously diagnosed concussion within the past year
- History of intracranial disease
- History of unresolved strabismus, diplopia, amblyopia
- History of unresolved cranial nerve III, IV or VI palsy
- History of unresolved macular edema, retinal degeneration, extensive cataract, or ocular globe disruption
- History of unresolved extensive corneal surgery or scarring
- Lack of two functional eyes
- Unresolved oculo-motor dysfunctions
- Obvious intoxication or impairment that limits ability to participate
- Imaging abnormality (i.e. fracture or bleed)
- Color blindness OR failing the Ishihara screening for color blindness
- Unable to come in for follow-up visits
- In addition to the above exclusion criteria, healthy control participants will be excluded if they have a history of chronic disease.
Where it is running
- CHOC Children's — Orange, California, United States (enrolling)
Full record on ClinicalTrials.gov
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